Amneal Pharmaceuticals Inc., a global biopharmaceutical company based in Bridgewater, New Jersey, has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for beclomethasone dipropionate HFA inhalation aerosol in 40 mcg and 80 mcg per actuation strengths.
The product is the generic equivalent of QVAR (beclomethasone dipropionate HFA) inhalation aerosol, a corticosteroid marketed by IVAX LLC, part of the Teva Group. It is indicated for the maintenance treatment of asthma as a prophylactic therapy in patients aged five years and older, but not for relief of acute bronchospasm.
This marks Amneal’s first metered-dose inhaler (MDI) product and represents a significant step in the company’s expansion into complex respiratory therapies within its Affordable Medicines segment.
“Our first metered-dose inhalation product is a landmark achievement for Amneal,”
said Dr. Srinivas Kone, Senior Vice President and Chief Scientific Officer – Affordable Medicines. “With additional inhalation programs advancing, we are well positioned to drive a new growth vector within our segment.”
Common adverse reactions associated with beclomethasone dipropionate HFA inhalation aerosol include headache, pharyngitis, rhinitis, upper respiratory tract infection, and sinusitis.
Amneal’s Affordable Medicines portfolio includes more than 280 pharmaceuticals across injectables, biosimilars, and other complex product categories, while its Specialty and AvKARE segments focus on branded therapies and distribution for U.S. government and institutional markets.
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